Administration of therapeutic or diagnostic agents using interlabial pad

Abstract

A drug or diagnostic agent) is delivered intravaginally or to the interlabial space by positioning an interlabial device, such as an absorbent pad, between the labia. The pad is retained between the labia to deliver an active agent, or allow a reaction with a diagnostic agent. Alternatively, the pad is applied after medication is administered, to help reduce discomfort to the subject, or loss of medication. The active agent may be carried by the pad itself, or in an intravaginal extension of the pad, or separately in a suppository or other dosage form. In particular examples, the pad has a smaller minor portion superimposed on a larger major portion, and the smaller minor portion is inserted as a leading edge between the labia of the subject to facilitate interlabial insertion. In another example, the pad is placed interlabially after insertion of an agent into the vagina.

I claim:  
     
       1. An interlabial delivery device comprising a delivery pad, wherein the pad is configured to be retained between labia of a subject, and the pad carries a therapeutically or diagnostically effective amount of a diagnostic or therapeutic agent; 
       wherein the pad has a minor portion superimposed on a major portion, the minor portion having a cross-sectional area smaller than a cross-sectional area of the major portion and wherein the minor portion is tapered to facilitate insertion between the labia and retention in the interlabial space, wherein the pad includes a cavity in an external surface of the pad, wherein substantially all the diagnostic or therapeutic agent is contained within the cavity.  
     
     
       2. The device of  claim 1 , wherein the agent is a transdermal agent. 
     
     
       3. The device of  claim 1 , wherein the pad is a highly absorbent non-swellable material. 
     
     
       4. The device of  claim 1 , wherein the pad is elongated to extend along the interlabial space to frictionally engage the pad against the labia and enable the pad to resist dislodgement. 
     
     
       5. The device of  claim 1 , wherein the agent is a drug in a unit dosage form. 
     
     
       6. The device of  claim 1 , wherein the minor and major portions of the pad have an elliptical cross-section with a major axis, wherein the major axis of the minor portion is less than the major axis of the major portion, and the major axis is of a sufficient size to retain the device substantially completely external to a vaginal orifice. 
     
     
       7. The device of  claim 1 , wherein the delivery material includes an agent for absorbing odors. 
     
     
       8. The device of  claim 1 , wherein the agent is a diagnostic agent. 
     
     
       9. The device of  claim 1 , wherein the agent is a therapeutic agent. 
     
     
       10. The device of  claim 1 , wherein the delivery device comprises an intravaginal portion and an extravaginal portion, and the intravaginal portion carries the agent to be delivered. 
     
     
       11. The device of  claim 1 , wherein the agent is an antibiotic or anti-fungal agent. 
     
     
       12. The device of  claim 1 , wherein the agent is a hormone. 
     
     
       13. A method for administering a drug to a subject, comprising inserting a pad impregnated with the drug into the subject's interlabial space, positioning the pad against the subject's external vaginal orifice, wherein the pad is devoid of corners and flat surfaces, and the pad has a minor portion superimposed on a major portion, the minor portion having a cross-sectional area smaller than a cross-sectional area of the major portion, wherein both the minor and the major portion are curvilinear in cross-section, and wherein the minor portion facilitates insertion between the subject's labia and retention in the interlabial space; and 
       retaining the pad in the interlabial space to dispense the drug interlabially, wherein the pad includes a recess that extends along an exterior surface of the pad, and in which the drug is placed, wherein compression of the pad compresses the recess to dispense the drug.  
     
     
       14. The method of  claim 13 , wherein the pad is elongated and has a uniform cross-section along its entire length, or is tapered along its length. 
     
     
       15. The method of  claim 13 , wherein the pad is elongated, and when placed in the interlabial space to dispense the drug, extends completely external to the vaginal orifice. 
     
     
       16. The method of  claim 13 , wherein the pad carries a therapeutically effective amount of a medicinal agent, and positioning the pad comprises administering the medicinal agent to the subject. 
     
     
       17. The method of  claim 13 , wherein the medicinal agent is an antifungal agent or a hormone. 
     
     
       18. The method of  claim 13 , wherein the minor and major portions of the pad have a length greater than their width, and the shape of the pad substantially conforms to the interlabial space in which the pad is retained. 
     
     
       19. The method of  claim 18 , wherein the pad is held between the labia without adhesive or attachment to a supporting garment. 
     
     
       20. The method of  claim 13 , wherein the major portion of the pad has longitudinally extending, opposed, substantially parallel face portions. 
     
     
       21. The method of  claim 20 , wherein the minor portion of the pad has longitudinally extending, opposed substantially parallel face portions. 
     
     
       22. The method of  claim 21 , wherein the opposed flat face portions of the pad are substantially parallel. 
     
     
       23. The method of  claim 22 , wherein the opposed flat face portions of the pad are substantially convergent. 
     
     
       24. The method of  claim 13 , wherein the minor portion of the pad has longitudinally extending, opposed substantially parallel face portions. 
     
     
       25. The method of  claim 24 , wherein the opposed flat face portions of the pad are substantially parallel. 
     
     
       26. The method of  claim 24 , wherein the opposed flat face portions of the pad are substantially convergent. 
     
     
       27. The method of  claim 13 , wherein the minor and major portions of the pad have a shoulder shaped junction. 
     
     
       28. The method of  claim 13 , wherein the pad carries a therapeutically effective amount of a medicinal agent, and positioning the pad comprises administering the medicinal agent to the subject to relieve the symptom. 
     
     
       29. The method of  claim 28 , wherein the medicinal agent is an anti-microbial or a hormone. 
     
     
       30. The method of  claim 13 , wherein the pad includes a cavity in which a medicinal agent is placed prior to positioning the pad. 
     
     
       31. The method of  claim 30 , wherein the cavity is compressed between the labia when the pad is positioned. 
     
     
       32. The method of  claim 31 , wherein the cavity communicates with an exterior surface of the pad. 
     
     
       33. The method of  claim 32 , wherein the cavity is a recess in an exterior surface of the minor portion of the pad. 
     
     
       34. The method of  claim 33 , wherein the pad is elongated, and the cavity extends longitudinally along the pad. 
     
     
       35. The method of  claim 13 , wherein the method further comprises applying medication intravaginally or perilabially prior to or simultaneously with positioning the pad.